ASEAN STANDARDS FOR
ANIMAL VACCINES
Second Edition
L i v e s t o c k P u b l i c a t i o n S e r i e s No.2A
CONTENTS
AVIAN VACCINES
AVIAN ENCEPHALOMYELITIS LIVE
AVIAN ENCEPHALOMYELITIS INACTIVATED
DUCK PLAGUE LIVE
EGG DROP SYNDROME 76 INACTIVATED
FOWL POX LIVE
FOWL CHOLERA BACTERIN
HAEMOPHILUS PARAGALLINARUM BACTERIN
INFECTIOUS BRONCHITIS LIVE
INFECTIOUS BRONCHITIS INACTIVATED
INFECTIOUS BURSAL DISEASE LIVE
INFECTIOUS BURSAL DISEASE INACTIVATED
INFECTIOUS LARYNGOTRACHEITIS LIVE
MAREK’S DISEASE LIVE
MYCOPLASMA GALLISEPTICUM BACTERIN
NEWCASTLE DISEASE (LENTOGENIC STRAIN) LIVE
NEWCASTLE DISEASE (MESOGENIC STRAIN) LIVE
NEWCASTLE DISEASE INACTIVATED
RIEMERELLA ANATIPESTIFER BACTERIN
VIRAL ARTHRITIS LIVE
SWINE VACCINES
ACTINOBACILLUS PLEUROPNEUMONIAE BACTERIN
AUJESKY’S DISEASE LIVE
AUJESKY’S DISEASE INACTIVATED
BORDETELLA BRONCHISEPTICA BACTERIN
FOOT-AND-MOUTH DISEASE FOR PIGS INACTIVATED
SWINE E. COLI BACTERIN
SWINE ERYSIPELAS BACTERIN
SWINE FEVER VACCINE (CELL CULTURE ORIGIN) LIVE
SWINE FEVER VACCINE (LAPINISED) LIVE
SWINE PASTEURELLA MULTOCIDA BACTERIN
RUMINANT VACCINES
ANTHRAX SPORE LIVE
BRUCELLA ABORTUS LIVE
BLACKLEG INACTIVATED
BOVINE VIRAL DIARRHOEA INACTIVATED
FOOT-AND-MOUTH DISEASE FOR
CATTLE AND BUFFALOES INACTIVATED
HAEMORRHAGIC SEPTICAEMIA FOR
CATTLE AND BUFFALOES BACTERIN
INFECTIOUS BOVINE RHINOTRACHEITIS LIVE
INFECTIOUS BOVINE RHINOTRACHEITIS INACTIVATED
OVINE ECTYMA (ORF) LIVE
SMALL ANIMAL VACCINES
CANINE CONTAGIOUS HEPATITIS INACTIVATED
FELINE PANLEUCOPENIA LIVE
FELINE PANLEUCOPENIA INACTIVATED
LEPTOSPIRA BACTERIN
RABIES FOR DOGS AND CATS INACTIVATED
APPENDIX
APPENDIX 1
APPENDIX 2
APPENDIX 3
APPENDIX 4
ASEAN STANDARD REQUIREMENTS FOR
AVIAN ENCEPHALOMYELITIS VACCINE, LIVE
I. SEED AND PRODUCTION SUBSTRATE REQUIREMENTS
1. SEED VIRUS
Master and working seed viruses are produced in Specific-Pathogen-Free (SPF) embryonated eggs in seed lot system. The seed viruses must satisfy sterility, purity, safety and potency tests before they are used for vaccine production. The seed viruses are lyophilized and kept at 2 to 10°C. Seed viruses in liquid form shall be stored at –50°C or lower.
2. PRODUCTION SUBSTRATE
Embryonated eggs used throughout the production of the vaccine must be derived from SPF flocks complying with tests that appear as Appendix 1.
II. QUALITY CONTROL REQUIREMENTS
1. STERILITY TEST
Final container samples should be tested for absence of bacteria, Salmonella, Mycoplasma and fungi by the methods that appear as Appendix 2. However, tests for Salmonella and Mycoplasma may be carried out on bulk samples.
2. PURITY TEST
Seedlot or bulk production samples should be tested for absence of extraneous viruses by the egg inoculation test or the chicken inoculation test or the tissue culture inoculation test, and by the test for Avian Leucosis Virus subgroups A and B using the methods that appear as Appendix 3.
3. SAFETY TEST
Final container samples should be tested by the following:
At least 10 susceptible chickens of the minimum age for which the vaccine is intended, are each inoculated with 10 doses of the vaccine by the recommended routes and observed for a minimum of 21 days. No clinical signs of Avian Encephalomyelitis (AE) should be observed in any of the chickens.
4. POTENCY TEST
Seed/bulk/final container samples should be tested as follows:
At least 10 susceptible chickens of the minimum age for which the vaccine is intended, are each inoculated with 1 dose of the vaccine by the recommended routes. At least 21 days post-vaccination, the vaccinates together with 10 unvaccinated controls are challenged with virulent AE virus by the intracerebral or intramuscular route and observed for a minimum of 21 days. At least 80% of the vaccinates should survive and show no clinical signs of the disease and at least 80% of the controls should die or show clinical signs of AE.
5. VIRUS CONTENT
The vaccine should have a virus titre of not less than 102.5 EID50 per dose when tested at any time before the expiry date.
III. OTHER REQUIREMENTS
The vaccine should comply with the General Requirements for Veterinary Vaccines that appear as Appendix 4.
ASEAN STANDARD REQUIREMENTS FOR
AVIAN ENCEPHALOMYELITIS VACCINE, INACTIVATED
I. SEED AND PRODUCTION SUBSTRATE REQUIREMENTS
1. SEED VIRUS
The master and working seed viruses are produced in Specific-Pathogen-Free (SPF) embryonated eggs in a seed lot system. The seed viruses must satisfy sterility, purity, safety and potency tests before they are used for vaccine production. The seed viruses are lyophilized and kept at 2 to 10°C. Seed viruses in liquid form shall be stored at –50°C or lower.
2. PRODUCTION SUBSTRATE
Embryonated eggs used throughout the production of the vaccine must be derived from SPF flocks complying with tests that appear as Appendix 1 or healthy flocks.
II. QUALITY CONTROL REQUIREMENTS
1. STERILITY TEST
Final container samples should be tested for absence of bacteria, fungi, Salmonella, and Mycoplasma by the methods that appear as Appendix 2. However, tests for Salmonella and Mycoplasma may be carried out on bulk samples. The test for Mycoplasma may be omitted if it can be demonstrated that the inactivating agent inactivates Mycoplasma.
2. PURITY TEST
Bulk production samples should be tested for absence of extraneous viruses by the egg inoculation test or the chicken inoculation test or the tissue culture inoculation test, and by the test for Avian Leucosis Virus subgroups A and B using the methods which appear as Appendix 3. This test may be omitted if it can be demonstrated that the inactivating agent inactivates avian leucosis viruses.
3. INACTIVATION TEST
At least 10 embryonated chickens eggs susceptible to avian encephalomyelitis (AE) virus are each inoculated with 0.2 ml of the inactivated product by the yolk sac route. The eggs are incubated for a minimum of 14 days. Brain samples are harvested from the embryos for a second passage. The inoculated eggs are examined after at least 14 days for signs of AE lesions. There should be no evidence of AE virus.
4. SAFETY TEST
Final container samples should be tested as follows:
At least 10 susceptible chickens of the minimum age for which the vaccine is intended, are each inoculated with at least 2 doses of vaccine by the recommended route and observed for a minimum of 14 days. No abnormal local or systemic reaction attributable to the vaccine should occur in any of the chickens.
5. POTENCY TEST
Bulk or final container samples should be tested as follows:
At least 10 susceptible chickens of the minimum age for which the vaccine is intended, are each inoculated with with 1 dose of the vaccine by the recommended route. At least 21 days post-vaccination, the vaccinates together with 10 unvaccinated controls are each challenged with virulent AE virus by the intracerebral route and observed for 14 days. At least 80% of the vaccinates should survive and show no clinical signs of disease and at least 80% of the controls should develop clinical signs of the disease or die.
III. OTHER REQUIREMENTS
The vaccine should comply with the General Requirements for Veterinary Vaccines that appear as Appendix 4.
ASEAN STANDARD REQUIREMENTS FOR
DUCK PLAGUE VACCINE, LIVE
I. SEED AND PRODUCTION SUBSTRATE REQUIREMENTS
1. SEED VIRUS
Master and working seed viruses are produced in Specific-Pathogen-Free (SPF) embryonated eggs or cell culture in a seed lot system. The seed viruses must satisfy sterility, purity, safety and potency tests before they are used for vaccine production. The seed viruses are lyophilized and kept at 2 to 10°C. Seed viruses in liquid form shall be stored at –50°C or lower.
2. PRODUCTION SUBSTRATE
Embryonated eggs or cell cultures used throughout the production of the vaccine must be derived from specific-pathogen-free (SPF) flocks complying with tests that appear as Appendix 1.
II. QUALITY CONTROL REQUIREMENTS
1. STERILITY TEST
Final container samples should be tested for absence of bacteria, Salmonella, Mycoplasma and fungi by the methods that appear as Appendix 2. However, tests for Salmonella and Mycoplasma may be carried out on bulk samples.
2. PURITY TEST
Seedlot or bulk production samples should be tested for absence of extraneous viruses by the egg inoculation test or the chicken inoculation test or the tissue culture inoculation test, and by the test for Avian Leucosis Virus subgroups A and B using the methods that appear as Appendix 3.
3. SAFETY TEST
Final container samples should be tested as follows:
At least 10 susceptible ducks of the minimum age for which the vaccine is intended, are each inoculated with 10 doses of the vaccine by the recommended routes. The ducks are observed clinically for 2 weeks. The vaccine is considered satisfactory if all of the ducks do not show any adverse systemic and local reactions.
4. POTENCY TEST
Seed/bulk/final container samples should be tested as follows:
At least 20 susceptible ducks of the minimum age for which the vaccine is intended, are each inoculated with 1 dose of the vaccine by the recommended route. At least 2 weeks post-vaccination, the vaccinates together with 10 unvaccinated controls are each challenged intramuscularly with 100 LD50 of a virulent Duck Plaque virus and observed for a minimum of 2 weeks post-challenge. At least 90% of the vaccinated ducks should remain healthy and show no clinical signs of the disease and at least 90% of the controls should die of Duck Plaque.
5. VIRUS CONTENT
The vaccine should have a virus titre of not less than 10 3.0 EID50 or TCID50/dose when tested at any time before the expiry date.
III. OTHER REQUIREMENTS
The vaccine should comply with the General Requirements for Veterinary Vaccines that appear as Appendix 4.
ASEAN STANDARD REQUIREMENTS FOR
EGG DROP SYNDROME 76 VACCINE, INACTIVATED
I. SEED AND PRODUCTION SUBSTRATE REQUIREMENTS
1. SEED VIRUS
The master and working seed viruses are produced in embryonated duck eggs derived from healthy flocks in a seed lot system. The seed viruses must satisfy sterility, purity, safety and potency tests before they are used for vaccine production. The seed viruses are lyophilized and kept at 2 to 10°C. Seed viruses in liquid form shall be stored at –50°C or lower.
2. PRODUCTION SUBSTRATE
Suitable cell culture or embryonated eggs used throughout production of the vaccine must be derived from healthy hen or duck flocks.
II. QUALITY CONTROL REQUIREMENTS
1. STERILITY TEST
Final container samples should be tested for absence of bacteria, fungi, Salmonella, and Mycoplasma by the methods that appear as Appendix 2. However, tests for Salmonella and Mycoplasma may be carried out on bulk samples. The test for Mycoplasma may be omitted if it can be demonstrated that the inactivating agent inactivates Mycoplasma.
2. PURITY TEST
Bulk production samples should be tested for absence of extraneous viruses by the egg inoculation test or the chicken inoculation test or the tissue culture inoculation test, and by the test for Avian Leucosis Virus subgroups A and B using the methods that appear as Appendix 3. This test may be omitted if it can be demonstrated that the inactivating agent inactivates avian leucosis viruses.
3. INACTIVATION TEST
At least 10 embryonated duck eggs susceptible to Egg Drop Syndrome 76 (EDS) virus are each inoculated with 0.2 ml of the inactivated product by the allantoic sac route. The eggs are incubated for a minimum of 3-7 days. One subculture is carried out. There should be no evidence of EDS virus. The test may be carried out in chicken embryo liver or duck embryo fibroblast cell cultures.
4. SAFETY TEST
Final container samples should be tested as follows:
At least 10 susceptible chickens of the minimum age for which the vaccine is intended, are each inoculated with at least 2 dose of the vaccine by the recommended routes. The chickens are observed clinically for 14 days. No abnormal local or systemic reactions attributable to the vaccine should occur in any of the chickens.
5. POTENCY TEST
Bulk or final container samples should be tested by one of the following methods:
a) At least 10 susceptible chickens of the minimum age for which the vaccine is intended, are each inoculated with 1/50 dose of vaccine by the recommended routes. At least 5 chickens are kept as unvaccinated controls. Three to 4 weeks post-vaccination, all chickens are serologically tested. At least 50% of the vaccinates should have haemagglutination inhibition (HI) antibody titres of at least 1: 16. The controls should remain negative.
b) At least 10 susceptible chickens of the minimum age for which the vaccine is intended, are each inoculated with 1 dose of vaccine by the recommended routes. At least 5 chickens are kept as unvaccinated controls. Three to 4 weeks post-vaccination, all chickens are serologically tested. The mean HI titre of the vaccinated group should be greater than 1: 128.
III. OTHER REQUIREMENTS
The vaccine should comply with the General Requirements for Veterinary Vaccines that appear as Appendix 4.
ASEAN STANDARD REQUIREMENTS FOR
FOWL POX VACCINE, LIVE
I. SEED AND PRODUCTION SUBSTRATE REQUIREMENTS
1. SEED VIRUS
Master and working seed viruses are produced in Specific-Pathogen-Free (SPF) embryonated eggs in a seed lot system. The seed viruses must satisfy sterility, purity, safety and potency tests before they are used for vaccine production. The seed viruses are lyophilized and kept at 2 to 10°C. Seed viruses in liquid form shall be stored at –50°C or lower.
2. PRODUCTION SUBSTRATE
Embryonated eggs used throughout the production of the vaccine must be derived from SPF flocks complying with tests that appear as Appendix 1.
II. QUALITY CONTROL REQUIREMENTS
1. STERILITY TEST
Final container samples should be tested for absence of bacteria, Salmonella, Mycoplasma and fungi by the methods that appear as Appendix 2. However, tests for Salmonella and Mycoplasma may be carried out on bulk samples.
2. PURITY TEST
Seedlot or bulk production samples should be tested for absence of extraneous viruses by the egg inoculation test or the chicken inoculation test or the tissue culture inoculation test, and by the test for Avian Leucosis Virus subgroups A and B using the methods that appear as Appendix 3.
3. SAFETY TEST
Final container samples should be tested as follows:
At least 10 susceptible chickens of the minimum age for which the vaccine is intended, are each inoculated with 10 doses of the vaccine by the recommended routes. The chickens are observed clinically for 3 weeks. The vaccine is considered satisfactory if all of the chickens do not show any adverse clinical signs of the disease.